Update to mdr submitted february 17, 2023.No correction to data.Updated based on investigation findings: 5 samples was returned for investigation.Four in original packing and one unpacked.All bags was found to be dented.Dented bag could support the report failure.Delivered volume test was performed on the samples.Test results show that four samples failed the test but one sample passed even though it was dented.The products was packed and controlled according to working instructions.Visual inspection was performed on the products during production and 100 % function test was performed during the production line.The resuscitators are packed into a carboard box according to work instruction and 100% visual inspection is performed on the package before delivery.The reported products should therefore be within specificaitons when shipped.The reported issue of the bag being collapsed and unable to re-inflate is suspected to be due to storage of the product in a compressed state at the customer which could cause the dents in the bag.As stated in the accompanying ifu, the resuscitator should never be stored in a deformed stated as permanent distortion of the bag may reduce the ventilation efficiency.According to the health care professional patient died was not related to the performance of the device but rather to the patient's condition.Even though there is no causality implied between patient outcome and device malfunciton the mdr is submitted since patient died.
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